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2022-07-22 07:30:30 By : Ms. Jenny Pang

PHOENIX (3TV/CBS 5) — The confines of her tiny apartment are both her refuge and her prison. Wisps of essential oils mist up from a glass diffuser. Crystals hanging in the single living room window reflect small rainbows, creating a hippy chic and soothing vibe. The efforts to create a comfortable environment are clear, but the harsh reality is, Ginger Peters feels she’s spent the last 11 years of her life dying a slow death.

Describing the 58-year-old as frail is an understatement. The slightest physical exertion, even showering, leaves her exhausted. Her current physical condition is a stark change from the once athletic woman who surfed and skied. At her lowest weight, the 5′9″ blond dropped to just 85 pounds, her flesh stretched across her protruding bones.

Peters says her life fell apart after a dentist convinced her to pull 22 teeth and replace them with dental implants. She says he told her it would help her recover from Valley fever. (Note: Health care professionals contacted during this investigation said they had not heard of pulling teeth to treat Valley fever.)

Dental implants consist of three parts. The base, considered the “implant,” is a screw-like piece that is drilled into the jawbone. The implant acts as “the root” of the artificial tooth. An abutment is a middle piece that attaches the implant base to the artificial tooth or teeth.

Peters says her new sets of teeth, both upper and lower, never fit correctly. Instead of locking into place, Peters’ artificial teeth fall out and move around in her mouth, leaving her unable to chew food.

A stack of medical records provided by Peters shows at least one of her doctors has linked a wide range of health and digestive problems to her implants and her inability to eat. However, no one has pinpointed why Peters has ongoing pain, infections, rashes on her face and neck and sores and inflammation in her mouth. Peters’ case is extreme but problems with dental implants are not uncommon.

A surge of reports of problems with dental implants may have remained almost impossible to find if it wasn’t for a former FDA data analyst. After leaving the FDA, Madris Kinard started Device Events. Her company specializes in searching through data in the FDA’s MAUDE database, which contains reports of the problems with medical devices reported to the FDA. MAUDE stands for Manufacturer and User Facility Device Experience.

MAUDE can be cumbersome and difficult to search, producing only 500 reports at a time. Kinard’s software sorts through millions of reports in seconds, allowing her to compile data that may take other researchers weeks to gather. Searching MAUDE, Kinard discovered dental implants have nearly 3 million reports of problems, more than any other medical device.

Kinard says the public has not been provided enough information on risks associated with dental implants. “Anybody who had looked at adverse events or problem reports with the devices over the last 20 to 25 years would have thought that were almost no problem with dental implants,” she said.

Reports of problems flew under the radar for decades, partly due to the fact the FDA had two separate systems for reporting problems. From 1995 to 2018, the MAUDE database received more than 58,000 reports of problems with dental implants. Those reports were available to the public. The relatively small number of reports each year created the appearance problems were rare.

A second system called Alternative Summary Reporting existed for manufacturers to report problems. The information in the ASRs was not publicly available. During the same time frame from 1995 to 2018, manufacturers reported more than 2.1 million problems with dental implants that were kept hidden. In an effort to create more transparency, in 2018, the FDA ended the use of ASRs and released decades of data. See Kris Pickel’s previous investigation on the FDA’s 2019 data dump.

Sorting through MAUDE, Kinard discovered reports of problems are currently surging. In 2018, the last year ASRs were used, there were less than 13,000 reports of problems with dental devices. In the past three years, possibly due to more awareness, reports have increased by more than 100,000 each year. In the first nine months of 2021, the FDA received more than 357,000 reports of problems with dental implants.

Kinard’s research also reveals out of the more than 2.9 million reports of problems, 88% are implants failing immediately or over time. A failure results in the patient losing the implant.

The FDA attributes the increase in reports of problems, in part, to more people getting dental implants. Nearly 3 million reports may sound surprising, but the true number of problems with dental implants could be even higher. FDA spokeswoman Stephanie Caccomo says MAUDE is important for detecting safety issues with medical devices, but it is only one of the tools used and has limitations. The database relies on health care professionals, patients and industry representatives taking the initiative to file the reports, which opens up “the potential submission of incomplete, inaccurate, untimely, unverified or biased data,” according to Caccomo.

Caccomo also notes MAUDE does not provide an accurate account of the rate of failure for a device “due to potential underreporting of events and lack of information about the frequency of device use.”

Some advertisements claim dental implants have success rates as high as 98%. What’s not revealed is that percentage is based on a study acknowledging the clinical trial does not reflect real-life situations. The study had less than 200 patients who were all in good health and were “optimal candidates for dental implants.” A patient’s health can play a key role in the success or failure of an implant and the loss of natural teeth can sometimes be tied to existing health issues.

Other studies examining factors that may contribute to a patient having problems with implants include:

There appears to be no way to accurately calculate the overall success or failure rate of dental implants. No agency or organization tracks how many dental implants are placed annually. In addition, none of the more than two dozen dental implant manufacturers contacted for this investigation were willing to answer questions.

If you turn on the television, there is a good chance you will see commercials touting the benefits of dental implants. Patient testimonials include glowing stories of new teeth transforming their smiles, giving them confidence, and improving their lives. With any medical procedure, patients are told to be informed but reliable information on the risks and complications associated with dental implants is difficult to find.

The FDA regulates medical devices. The agency’s website includes pages detailing warnings for everything from hip and breast implants to blood glucose monitoring. Until recently, warnings for dental implants fell under a generic page titled “Implants and Prosthetics.” The webpage does not mention the words “dental implants.”

After the FDA was presented with the information in this investigation, including the increasing number of reports of problems in the agency’s MAUDE database, the FDA reacted within a matter of weeks, creating a webpage dedicated to the benefits and risks of dental implants titled: Dental Implants: What You Should Know.

The website encourages people who experience problems to file a voluntary report through MedWatch but does not alert the public to the millions of issues already reported. Kinard says it’s past time for the FDA to provide stronger warnings on the surging number of implant failures. “It’s very concerning to me. I’m not sure why the FDA hasn’t put out any kind of notification to patients and physicians,” says Kinard.

The answer to that question is, you don’t know. You can find out more about what’s in your snack than what’s in your dental implant. The FDA requires ingredients in food to be listed. Dental implants don’t require the same transparency. To get on the market, dental implant manufacturers only have to show their device is “similar to a previously approved product.”

In documentation provided to the FDA, dental implant manufacturers can list general materials such as titanium alloys. An alloy is a mixture of metals. However, the other metals are not revealed. This means you can learn more about the ingredients in a frozen burrito by reading the packaging than what’s in a medical device you implant in your body.

Dr. Dirk Duddeck runs the Clean Implant Foundation, a laboratory in Berlin accredited by the German government that analyzes dental implants looking for contaminants.

He says over the past few years, using a cleanroom to avoid being the source of contamination, he’s analyzed more than 300 different dental implants and found contamination on roughly three out 10 implants that are supposed to be sterile. Contaminants, according to Duddeck, include everything from toxic chemicals used in production to tiny metal particles including iron, chromium, nickel, tungsten, copper and tin. Duddeck details his research in a video:

According to Duddeck, the contamination may lead to the body rejecting the implants as it tries to get rid of the particles.

Prior to Peters getting her dental implants, she says she told the dentist she was allergic to some metals but was told people can’t be allergic to titanium. Allergic reactions to titanium are rare but can happen. For this investigation, Peters agreed to take a blood test used to diagnosis metal hypersensitivity.

The results of a MELISA test came back negative for a titanium allergy but revealed Peters is allergic to nickel. Studies and discussion papers show nickel has been found in some dental implants. The maker of Peters’ dental implant did not respond to questions on if their implants contain nickel.

Dr. James Yiannias, a dermatologist with the Mayo Clinic, says 20% of people tested for allergies come back positive for nickel allergies. However, he points out most nickel allergies are associated with people wearing costume jewelry containing nickel.

He says if a patient is allergic to a metal in a dental implant, symptoms would include redness and irritation in the tissue immediately adjacent to where the metal is located. However, he warns against jumping to the conclusion that inflammation around dental implants is due to an allergic reaction. He cautions that similar symptoms can be caused by immune disorders, which he advises patients should be tested for.

Yiannias says he has seen allergic reactions to mercury and gold inside a patient’s mouth but he’s never linked an allergic reaction to nickel in a dental implant. He’s also cautioned that he has seen patients remove their dental implants over allergy concerns, but the patients continued to suffer symptoms.

Dr. Terry Work has been using dental implants for 15 years and is a consultant for the Arizona State Board of Dental Examiners, where he investigates complaints about dental implants. Work says implants are “exceptionally safe,” but like any other medical procedure, there can be complications. For dentists, the failure of implants is “an accepted part of providing the service,” but he warns that not all clinicians are equal when it comes to training and skill.

“Some clinicians are more careful than others and there are different manufacturers. The same implant in two different people’s hands can have a little bit different success rate,” Work said.

In addition to the person’s skill level performing the procedure, a patient’s health can also affect an implant’s success or failure. “If you have someone that’s in poor health or has poor oral hygiene, they may not be a great candidate. It doesn’t mean you can’t place implants in them, but what it means is, you have to tell them, ‘Listen, these are the possible outcomes,’” says Work.

Dental implants can cost thousands of dollars per tooth. Peters was charged $32,000 for her implants and says she never thought complications would cost her health.

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